A Step To Progress?

DCG(I) has come up with mandatory provisions for pharma companies to undergo stability tests for approval of drugs in India. Though it will raise the standard for quality of drugs in the global market, it will also have considerable impact on pharma company’s bottom line. Industry experts have a mixed bag of opinions

- Usha Sharma

Bhavin Mehta, Director, Kilitch Drugs

The Indian pharmaceutical sector is a huge industry with a significant growth potential. The industry comprises large, medium and small-scale drug companies that are expanding its presence not only in the domestic market, but in the export markets as well. Globally, the industry’s drugs find markets in the US, the European Union, the Middle-East, African continent and South-East Asia. To cater to these growing overseas segments, it is essential that the industry invests significantly in research and development, manufacturing facilities and developing newer markets. Further, to ensure that these are continuously sustained at the beginning stage of a drug’s life cycle as well as at subsequent stages, quality of the drug is an imperative.

With a view to encourage pharma exports, the Government of India has recently amended the provisions of Market Access Initiative (MAI) scheme. In particular, this is important from the perspective of SME pharma players, who are expected to contribute to the industry’s double-digit growth, in no small measure.

While this is a welcome step in the right direction, there is one more recent announcement by the country’s drug regulator, the Central Drugs Standards Control Organisation (CDSCO), which the players are not too happy about. As part of the amendments to Drugs and Cosmetics Rules, 1945, henceforth ‘stability testing’ has been made mandatory for all drugs and formulations before they access the market. The new rule applies to all drugs, active pharmaceutical ingredients (API)s, raw materials used in a drug, new drugs and even to older drugs which are already in the market for a long time.